β blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial

β blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial
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DOI:
10.1016/s0140-6736(18)31875-0
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发表时间:
2019-04-20
期刊:
影响因子:
168.9
通讯作者:
Planas, R.
Planas, R.
中科院分区:
医学1区
文献类型:
--
作者:
Villanueva, Candid;Albillos, Agustin;Planas, R.

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背景 肝硬化的临床失代偿与不良预后相关。具有临床意义的门静脉高压 (CSPH),定义为肝静脉压力梯度 (HVPG) >= 10 mm Hg,是失代偿的最强预测因子。本研究旨在评估用 β 受体阻滞剂降低 HVPG 是否可以降低代偿性肝硬化伴 CSPH 失代偿或死亡的风险。 方法 这项关于 β 受体阻滞剂预防门脉高压肝硬化失代偿的研究 (PREDESCI) 是一项由研究者发起、双盲、随机对照试验,在西班牙八家医院进行。我们招募了代偿性肝硬化和 CSPH 且无高危静脉曲张的患者。所有参与者均进行了 HVPG 测量,评估静脉注射普萘洛尔的急性 HVPG 反应。有反应者(HVPG 降低 >= 10%)被随机分配至普萘洛尔(最多 160 毫克,每天两次)组,与安慰剂组和卡维地洛无反应者(
Background Clinical decompensation of cirrhosis is associated with poor prognosis. Clinically significant portal hypertension (CSPH), defined by a hepatic venous pressure gradient (HVPG) >= 10 mm Hg, is the strongest predictor of decompensation. This study aimed at assessing whether lowering HVPG with beta blockers could decrease the risk of decompensation or death in compensated cirrhosis with CSPH.Methods This study on beta blockers to prevent decompensation of cirrhosis with portal hypertension (PREDESCI) was an investigator-initiated, double-blind, randomised controlled trial done in eight hospitals in Spain. We enrolled patients with compensated cirrhosis and CSPH without high-risk varices. All participants had HVPG measurements with assessment of acute HVPG-response to intravenous propranolol. Responders (HVPG-decrease >= 10%) were randomly assigned to propranolol (up to 160 mg twice a day) versus placebo and non-responders to carvedilol (